Kornimate/medical-research-clean huggingface dataset:
clinical outcome in patients with inph

Conditions: Hydrocephalus; Idiopathic Normal Pressure Hydrocephalus; CSF; Glympathic System; Omic

Summary: the aim of this study is to determine the clinical spectrum and natural progression of idiopathic normal pressure hydrocephalus （inph ) and related disorders in a prospective single center study, identify digital, imaging and molecular biomarkers that can assist in diagnosis and therapy development and study the etiology and molecular mechanisms of these diseases.

due to the heterogeneity of the etiology of idiopathic normal pressure hydrocephalus , almost all published studies on the clinical outcome and prognostic factors of inph are relatively limited, and most of them are retrospective. it is not clear which is the most reliable predictor of clinical outcome. therefore, the researchers conducted this prospective cohort study to identify the occurrence, development and outcome of inph and determine the main prognostic factors through clinical scales, biomarkers and imaging. at study visits a standardized clinical examination will be performed including application of clinical rating scales. at all study visits, patients will be asked to donate biosamples; biomaterial collection is optional and participants can elect to participate in sampling of blood, urine, csf, and/or a muscle biopsy. optionally, additional examinations may be performed including imaging，such as dtialps, neurophysiological examination, analysis of patient or observer reported outcomes and analysis to characterize molecular biomarkers.

Eligibility criteria:
inclusion criteria: * patients who was diagnosed as idiopathic normal pressure hydrocephalus exclusion criteria: * patient received surgical treatment or interventional treatment before patient is pregnant patient unable to complete follow-up patient with other types of hydrocephalus other nervous system diseases

Keywords: hydrocephalus idiopathic normal pressure hydrocephalus
safety and immunogenicity of surface antigen, inactivated, adjuvanted with mf59c.1 influenza vaccine, formulation 2008-2009

Conditions: Interpandemic Influenza

Summary: trial for annual approval of interpandemic influenza vaccines


Eligibility criteria:
key inclusion criteria: * 65 years of age or older * mentally competent * willing and able to give written informed consent prior to study entry * able to comply with all the study requirements * in general good health key exclusion criteria: * any serious chronic or acute disease * history of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study vaccine (e.g. to ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate); * known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age) * receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivates within the past 3 months and for the full length of the study; suspected or known hiv infection or hiv-related disease * a bleeding diathesis or condition associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject * within the past 12 months, they have received more than one injection of influenza vaccine * within the past 6 months, participants had laboratory confirmed influenza disease; received influenza vaccine * within the past 4 weeks participants had received another vaccine; any investigational agent * an acute exacerbation of a copd (chronic obstructive pulmonary disease) within the past 14 days

Keywords: prophylaxis of influenza influenza vaccines mf59c.1
a follow-up study to evaluate the efficacy and safety of allo-asc-dfu in allo-asc-eb-101 clinical trial

Conditions: Dystrophic Epidermolysis Bullosa

Summary: this is an open-label follow up study to evaluate the safety for the subjects with allo-asc-dfu treatment in phase 1/2 clinical trial(allo-asc-eb-101) for 24 months.

this is an open-label follow up study to evaluate the efficacy and safety for the subjects with allo-asc-dfu treatment in phase 1/2 clinical trial (allo-asc-eb-101) for 24 months. allo-asc-dfu is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. adipose-derived stem cells have anti-inflammatory effect and release growth factors such as vascular endothelial growth factor(vegf) and hepatocyte growth factor (hgf), which can enhance wound healing and regeneration of new tissue, finally may provide a new option in treating a dystrophic epidermolysis bullosa.

Eligibility criteria:
inclusion criteria: 1. subjects who are treated with allo-asc-dfu sheet in phase 1/2 clinical trial of allo-asc-eb-101. 2. a subject who is willing to follow the protocol and provide informed consent on screening, given that the information with respect to the clinical trial is provided. exclusion criteria: 1. subjects who are considered not suitable for the study by the principal investigator.

Keywords: epidermolysis bullosa stem cell
phase 1 study of autologous cd30.car-t in relapsed or refractory cd30 positive non-hodgkin lymphoma

Conditions: Anaplastic Large Cell Lymphoma; Peripheral T Cell Lymphoma; Extranodal NK/T-cell Lymphoma; Diffuse Large B Cell Lymphoma; Primary Mediastinal Large B-Cell Lymphoma (PMBCL)

Summary: this is a phase 1 study to evaluate safety and dose-limiting toxicity of autologous cd30.car-t in subjects with relapsed or refractory cd30+ non-hodgkin lymphoma

adult patients with relapsed or refractory cd30-positive non-hodgkin lymphoma who have failed standard available therapies and who meet eligibility criteria will have blood drawn to manufacture the cd30.car-t cells. cd30.car-t cells will be infused once following the completion of lymphodepleting chemotherapy with bendamustine and fludarabine. subjects will be closely monitored for dlt and safety.

Eligibility criteria:
inclusion criteria: eligibility is determined priori to leukapheresis. patients must satisfy the following criteria to be enrolled in this study: 1. signed informed consent form 2. male or female patients who are 18-75 years of age 3. histologically confirmed alcl, ptcl- nos, enktcl nasal type, dlbcl-nos and pmbcl 4. relapsed or refractory cd30-positive nhl who have failed all available standards of therapy. patients may or may not have received an autologous or allogeneic hsct cd30-positive tumor 5. at least 1 measurable lesion according to the lugano classification 6. ecog ps of 0 to 1 or equivalent karnofsky ps anticipated life expectancy \>12 weeks exclusion criteria: 1. cns involvement by malignancy 2. inadequate laboratory abnormalities at screening: hgb ≤ 8.0 g/dl total bilirubin \> 1.5 x uln (\>2 x uln for patients with gilbert's syndrome) ast and alt ≥ 5 x uln crcl ≤ 45 ml/min (as measured by cockcroft-gault equation) anc ≤ 1000/ul platelets ≤75,000/ul pr or inr \>1.5 x uln aptt\> 1.5 x uln 3. active uncontrolled bleeding or a known bleeding diathesis 4. inadequate pulmonary function defined as pulse oximetry \< 90% on room air 5. ongoing treatment with immunosuppressive drugs including calcineurin inhibitions, tnfalpha, mtor, etc or chronic systemic corticosteroids (\>10 mg/day prednisone or equivalent for \>48 hours) 6. received prior therapy of: anti-cd30 ab based therapy within the previous 8 weeks previous cd30.car-t investigational product bi-specific cd30 ab within the previous 8 weeks allogenic hsct in the last 180 days autologous hsct within 90 days 7. active gvhd requiring immune suppression regardless of grade 8. hiv positive 9. active hbv and/or hcv

Keywords: cd30, r/r nhl, dlbcl, alcl, enktcl, pmbcl, ptcl, adult
molecular and structural imaging in alzheimer's disease: a longitudinal study

Conditions: Atypical Alzheimer's Disease; Logopenic Progressive Aphasia (LPA); Posterior Cortical Atrophy (PCA); Alzheimer Disease; Alzheimer Disease, Early Onset; Amnestic Disorder; Amnestic Symptoms; Amnestic Mild Cognitive Disorder

Summary: this is a neuroimaging study designed to learn more about amyloid and tau burden in the brain of patients with typical and atypical alzheimer's disease and how burden may change over a one year period.


Eligibility criteria:
inclusion criteria: * over the age of 21 * must have an informant who will be able to provide independent evaluation of functioning * english is primary language * all subjects must have insidious onset, report progression of their symptoms, and meet current clinical diagnostic criteria for typical amnestic ad or an atypical ad syndrome such as logopenic aphasia (lpa) or posterior cortical atrophy (pca). * all subjects with logopenic aphasia (lpa) must present with early and dominant impairments in language * all subjects with typical amnestic ad must have relative preservation of episodic memory compared to impairment in the non-episodic memory domain exclusion criteria: * if you have had a stroke or tumor that could explain your symptoms * subjects that present with early episodic memory impairment or meet clinical criteria for mild cognitive impairment will not be recruited into the study * subjects that meet specific criteria for another neurodegenerative disorder, including behavioral variant frontotemporal dementia, semantic dementia, primary progressive apraxia of speech, probable corticobasal syndrome, or progressive supranuclear palsy, will be excluded * subjects will be excluded if they have poor vision (20/400) * women that are pregnant or post-partum and breast-feeding will be excluded * subjects will be excluded from the study if they are unable to undergo the tau-pet scan due to a prolonged qt interval on ecg, or if they have any of the following genetic conditions which can increase the chance of cancer: cowden disease, lynch syndrome, hypogammaglobulinemia, wiskott-aldrich syndrome, and down's syndrome * subjects will also be excluded if mri is contraindicated (metal in head, cardiac pace maker, e.t.c.), if there is severe claustrophobia, if there are conditions that may confound brain imaging studies (e.g. structural abnormalities, including subdural hematoma or intracranial neoplasm), or if they are medically unstable or are on medications that might affect brain structure or metabolism,(e.g. chemotherapy)

Keywords: pca lpa ad amnestic ad
efficacy of electro-acupuncture for abdominal obesity: study for a randomized controlled trial

Conditions: Obesity, Abdominal

Summary: electro-acupuncture provides stimulation to acupoints, and has been widely used to treat abdominal obesity in china despite of lack of high-level evidence for treatment efficacy. the study will investigate whether the electroacupuncture can alleviate clinical symptoms and the mechanism of action in patients with abdominal obesity.

the study will be a randomized controlled trial from may 2021 to december 2022, including 68 participants with abdominal obesity. the participants will be randomly divided into 2 groups in a 1:1 allocation ratio.the intervention group will receive electroacupuncture; the control group will receive sham acupuncture. each treatment will last 12 weeks, including 8 weeks of intervention period and 24 weeks of follow-up. the primary outcome is the waist circumference (wc), the secondary outcomes include weight, body mass index (bmi), hipline, waist-hip-ratio (whr), insulin resistance index (iri), blood fat, metabolomics will be used analysis the mechanism. the adverse events will be recorded during the intervention and follow-up period.

Eligibility criteria:
inclusion criteria: * patients recruited for this study should meet the following inclusion criteria: 1.satisfying the criteria for the diagnosis of abdominal obesity; 2.18 years old≤age≤55 years old; 3.being able to fully understand and voluntarily sign informed consent. exclusion criteria: * patients with any of the following criteria will be excluded from the study: 1. presence of endocrine disorders such as: polycystic ovary syndrome; cushing's syndrome; uncorrected thyroid disease. 2. presence of diabetes mellitus, or hypertension, or abnormal liver and kidney functions, or mental diseases. 3. pregnant or lactating state, women who plan to become pregnant within 12 weeks. 4. history of bulimia, anorexia, or any other eating disorders. 5. use of medications in the past 3 months, such as diet drugs, corticosteroids, antidepressants, which may affect weight or appetite. 6. history of surgical weight loss, postoperative adhesions. 7. history of participating in a clinical study of weight loss or any other therapies to lose weight in the past 3 months. 8. unable to cooperate with the research caused by other diseases or reasons. 9. received acupuncture within 6 months before enrollment

Keywords: abdominal obesity electro-acupuncture randomized controlled trial
characteristic transcriptomic, proteomic and metabolomic molecular studies of nasal secretions from chronic rhinitis

Conditions: Chronic Rhinitis

Summary: chronic rhinitis is a common chronic nasal mucosal inflammatory disease. its clinical symptoms and severity are diverse, mainly including allergic rhinitis, local allergic rhinitis, non-allergic rhinitis with hypereosinophilia syndrome and idiopathic rhinitis. all kinds of rhinitis have clinical symptoms such as nasal congestion, runny nose, sneezing, and nasal itching, but the causes are different. at present, the complicated diagnostic methods of different subtypes of chronic rhinitis are an important factor restricting the improvement of clinical diagnosis and treatment. based on the found key markers of each subtype of chronic rhinitis, the establishment of a non-invasive classification diagnostic method of chronic rhinitis with nasal secretion as the core is of great practical significance for optimizing the existing clinical diagnosis system and improving the efficiency of clinical diagnosis

to study the characteristic transcriptome, proteome and metabolome molecules of nasal secretions of different subtypes of chronic rhinitis, and to establish a non-invasive diagnostic method for chronic rhinitis based on nasal secretions.nasal secretions and blood were collected from patients with chronic rhinitis.

Eligibility criteria:
inclusion criteria: 1. age 18-65 years old; 2. patients with chronic rhinitis in the department of otorhinolaryngology, the first affiliated hospital of nanjing medical university; 3. patients who are willing to provide specimens for free to promote the diagnosis of chronic rhinitis. exclusion criteria: 1. patients received glucocorticoids, immunomodulatory drugs, antihistamines, and other treatments that may affect the study results within the past 1 month. 2. patients with unstable diseases (including severe asthma) and active immune system diseases; 3. smoking; 4. pregnant or lactating women; history of nasal surgery within 5.3 months; 6. patients with low compliance and refusing to accept specimen and questionnaire collection
acupuncture acl (anterior cruciate ligament)

Conditions: ACL; ACL Injury; Anterior Cruciate Ligament Injury; Anterior Cruciate Ligament Rupture; Anesthesia

Summary: acupuncture research in regards to ponv has been fairly well established, however, studies about perioperative pain control and acupuncture are a little more murky. in 2008, a meta analysis looked at randomized controlled studies and found that while acupuncture was shown to decrease pain, there were limitations including credible placebo or sham intervention, and thus, blinding. the main purpose of this feasibility trial is to determine whether or not adequate blinding is possible in the intraoperative setting with the patient sedated.

according to the most recent survey conducted by the national center for complementary and integrative health (a branch of the national institutes of health) in 2007, the use of complementary alternative medicine (cam) has increased significantly from 2002 (the previous survey). in the 2007 survey, in the united states alone, 38% percent of adults and 12% of children use some form of cam. it has been 10 years since that survey report, there is little doubt that these numbers have only increased. according to the national center for health statistics on the expenditures on cam in 2012 - for just adults utilizing specialists, such as acupuncturists, $14.1 billion was spent. with this increasing demand of such treatment modalities by patients, conventional practitioners will need to be, at the very least, well versed enough to recommend for or against these modalities. in addition, the current opioid epidemic is on the forefront of the public mind. recently declared a public health emergency by the president, alternative means of postoperative pain control is a necessity and integrative medicine is a low cost, safe, and effective adjuvant/alternative

Eligibility criteria:
inclusion criteria: * patients undergoing acl surgery with a participating surgeon * english speaking * patients at least 12 years old * planned spinal anesthesia without peripheral nerve block (rescue block is okay) exclusion criteria: * patients under the age of 12 * non-english speaking patients * patients planning on having general anesthesia * planned preop peripheral nerve block * patients with the inability to understand/follow study protocol * patients with pacemaker/aicd * non-native ear/previous scarring/surgical manipulation of ear * patients with contraindications to intra-op protocol * chronic pain patients * patients who have regularly used opioids for more than 6 weeks prior to surgery * patients with guages in their ears * patients who refuse to remove earrings/piercings prior to surgery * patients with nickel allergies (needles are made of nickel)

Keywords: acupuncture
right ventricular contractility reserve following repair of tetralogy of fallot

Conditions: Right Ventricular Dysfunction

Summary: background: residual pulmonary regurgitation following repair of tetralogy of fallot, in particular the use of a transannular patch, has been shown to correlate with the development of right ventricular dysfunction. optimal timing of pulmonary valve replacement, therefore, is important to preserve right ventricular function. several recent studies suggested that a threshold of right ventricular end-diastolic volume for intervention, in order to preserve the likelihood of adequate reverse remodeling, is in the region of 150 to 200 ml/m2 body surface area. however, there is evidence that right ventricular function does not always recover following pulmonary valve replacement even if the end-diastolic volume is below this cut-off. in addition, previous studies suggested that early dysfunction may be present before symptoms occur. however, early dysfunction is difficult to assess. methods: analysis of right ventricular function by pressure-volume loops has been extensively evaluated in experimental studies and is generally considered the optimal way to quantify right ventricular function. by recording a family of pressure-volume loops during reduction of preload, achieved by temporary balloon occlusion of the inferior caval vein, the contractility can be calculated by the slope of the endsystolic pressure-volume relation (elastance). changes of contractility following dobutamine infusion could be noted by changes of elastance. the increase of the slope during dobutamine demonstrates the contractility reserve of the right ventricle. purpose: to evaluate the right ventricular contractility reserve to determine early ventricular dysfunction after repair of tetralogy of fallot.


Eligibility criteria:
inclusion criteria: 1. corrected tetralogy of fallot or other surgery with involvement of the pulmonary valve, chronic pulmonary regurgitation, dilated right ventricle 2. patient's age \> 4 years 3. routine cardiac catheterization clinically indicated for deciding therapeutic treatment 4. informed assent/consent of patients/parent. exclusion criteria: 1. pregnancy/breast feeding, women of child-bearing age without contraception. 2. present participation, and/or participation in a clinical study during the last 4 weeks. 3. illnesses or malfunctions, which exclude a participation in this study after decision of the investigating physician. 4. other medical, psychological or social circumstances which complicate a regular participation in the study, and/or increase the risk for the patients themselves.

Keywords: tetralogy of fallot right ventricular dysfunction pulmonary insufficiency pulmonary valve replacement pressure-volume loops long-term follow-up in tetralogy of fallot
a dose escalation study of tenofovir alafenamide in treatment-naive patients

Conditions: HIV Infections

Summary: this study evaluated two doses of tenofovir alafenamide versus tenofovir disoproxil fumarate (tenofovir df).


Eligibility criteria:
inclusion criteria * hiv-1 rna levels greater than or equal to 30,000 copies/ml * cd4 count greater than or equal to 200 cells/mm3 * serum creatinine \<1.5 mg/dl * hepatic transaminases less than or equal to 2.5 times the upper limit of normal * total bilirubin less than or equal to 1.5 mg/dl * adequate hematologic function * serum amylase less than or equal to 1.5 times the upper limit of normal * serum phosphate greater than or equal to 2.2 mg/dl * not pregnant exclusion criteria * prior treatment with antiretroviral therapy * immunization within 30 days of study entry * a new aids defining condition within 30 days of study entry * receiving nephrotoxic agents, probenecid, chemotherapeutic agents, corticosteroids, interleukin-2

Keywords: treatment naive